Alembic Pharma subsidiary bags USFDA nod for Adapalene, Benzoyl peroxide topical gel
The gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older, the company said
New Delhi: Alembic Pharmaceuticals on Monday announced that the company's wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic version of a topical gel used to treat acne vulgaris.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for adapalene and benzoyl peroxide topical gel of strength 0.3 per cent/2.5 per cent, Alembic said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte topical gel of Galderma Laboratories, L.P., it added.
The gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older, the company said. Acne vulgaris is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles.
Citing IQVIA data, Alembic said adapalene and benzoyl peroxide topical gel, 0.3 per cent/2.5 per cent had an estimated market size of USD 211 million for the 12 months ended March 2022.
The company has so far received 170 ANDA approvals (146 final approvals and 24 tentative approvals) from the USFDA, the statement said.
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Medical Dialogues team had earlier reported that Aleor Dermaceuticals Limited had received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Adapalene Gel USP, 0.3%.
Read also: Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for Adapalene Gel
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. The company is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Manufacturing facilities, which cater to the International Generics markets are located at Panelav, Karkhadi and Jarod in Gujarat. The company's APIs are manufactured at the Panelav and Karkhadi facilities.
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